Device Classification Name |
reagent, borrelia serological reagent
|
510(k) Number |
K943812 |
Device Name |
VIDAS LYME SCREEN II |
Applicant |
BIOMERIEUX VITEK, INC. |
1022 HINGHAM ST. |
ROCKLAND,
MA
02370
|
|
Applicant Contact |
TERRY MCGOVERN |
Correspondent |
BIOMERIEUX VITEK, INC. |
1022 HINGHAM ST. |
ROCKLAND,
MA
02370
|
|
Correspondent Contact |
TERRY MCGOVERN |
Regulation Number | 866.3830
|
Classification Product Code |
|
Date Received | 08/05/1994 |
Decision Date | 06/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|